Comparison of Self- and Balloon-expandable Valves in Patients With Ascending Aortic Dilation Undergoing Transcatheter Aortic Valve Replacement: The AAD-CHOICE
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The rate of device success
研究概览
简要总结
This study aimed at comparing the performance of self-expandable valves versus balloon-expandable valves in patients with ascending aortic dilation undergoing transcatheter aortic valve replacement.
详细描述
Ascending aortic (AA) dilation is a common feature in patients with aortic stenosis (AS), especially in those with bicuspid aortic valve (BAV). For patients undergoing surgical aortic valve replacement (SAVR), current guidelines recommend concomitant aortic repair or replacement if the diameter of AA exceeds 45mm to avoid aortic dissection or rupture.
Transcatheter aortic valve replacement (TAVR) has profoundly changed the clinical management of AS patients who cannot tolerate SAVR. For patients who are candidates for TAVR, simultaneous repair of a dilated AA can be technically difficult. The safety and feasibility of the procedure and the fate of AA after the procedure in these patients remain unclear. Moreover, there are limited data comparing the performance of self-expandable valves versus balloon-expandable valves in these patients. The aim of the present study is to evaluate the impact of type of transcatheter heart valves on intra-procedural device success and post-procedural AA progression in patients with dilated AA (≥45mm) undergoing TAVR.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Surgeons are aware of randomisation results, however, participants and research staff are all blinded to the randomisation schemes.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe aortic stenosis;
- •Transfemoral access;
- •Preoperative aortic CT suggesting maximum ascending aortic diameter ≥45mm and <55mm;
- •Anticipated life expectancy >1 year;
- •Age ≥ 65 years.
排除标准
- •Dominant aortic regurgitation,;
- •A history of SAVR or TAVR;
- •A history of aortic surgery;
- •Emergent TAVR.
研究组 & 干预措施
Self-expandable valve group
Patients using self-expandable valves
干预措施: self-expandable valves (Device)
Balloon-expandable valve group
Patients using balloon-expandable valves
干预措施: balloon-expandable valves (Device)
结局指标
主要结局
The rate of device success
时间窗: 30 days
Device success is defined as following: 1. Technical success (Freedom from mortality; Successful access, delivery of the device, and retrieval of the delivery system; Correct positioning of a single prosthetic heart valve into the proper anatomical location; Freedom from surgery or intervention related to the device or to a major vascular or access-related, or cardiac structural complication) 2. Freedom from mortality 3. Freedom from surgery or intervention related to the device or to a major vascular or access-related or cardiac structural complication 4. Intended performance of the valve (mean gradient \<20 mmHg, peak velocity \<3 m/s, Doppler velocity index $0.25, and less than moderate aortic regurgitation)
30-day all-cause mortality
时间窗: 30 days after TAVR procedure
all-cause mortality within 30 days after TAVR procedure
30-day adverse aortic events
时间窗: 30 days after TAVR procedure
aortic death, aortic dissection, or aortic rupture
次要结局
- Hospitalization (or re-hospitalization)(1 year after TAVR procedure)
- 1-year cardiovascular mortality(1 year after TAVR procedure)
- 1-year adverse aortic events(1 year after TAVR procedure)
- 1-year all-cause mortality(1 year after TAVR procedure)
- Ascending aortic diameter expansion rate ≥3mm/year(1 year after TAVR procedure)